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Taking people in United StatesPhase 1/2

Tests REGN10597 alone or with cemiplimab in adults with advanced solid tumors

Tests an experimental drug, alone or with cemiplimab, in adults with advanced solid tumors.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Chapel Hill, Chicago, Grand Rapids, Houston, Lake Success, Los Angeles, North Haven, Pittsburgh, San Antonio, and San Francisco, United StatesSee the 11 sitesAlso in 4 other countries, 19 sites
Registry title
A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
Status
Recruiting
Phase
Phase 1/2
People taking part
240 people, planned
Started
23 Sept 2024
Expected to end
3 Feb 2030
Type of study
Interventional, 4 groups
Treatments tested
  • REGN10597
  • Cemiplimab
Record updated
28 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an advanced solid tumor, such as melanoma or clear-cell kidney cancer, to test REGN10597 alone or with cemiplimab.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced solid cancer confirmed by tissue or cell tests, either locally advanced or spread. In the first part, the cancer has grown despite standard treatment. Later groups are melanoma or kidney cancer (RCC) that grew after anti-PD-(L)1 treatment, or first-line melanoma.
Earlier treatment
In the first part, the cancer must have grown despite standard treatment. Later groups need melanoma or kidney cancer that grew after anti-PD-(L)1 treatment, or first-line melanoma. People cannot have had IL2, IL15 or IL-7 treatment outside adoptive cell therapy. People cannot have had anti-PD1/PD-L1 treatment as defined in the protocol.

Main reasons for not taking part

  • Prior IL2, IL15 or IL-7 treatment outside adoptive cell therapy
  • Anti-PD1/PD-L1 or other recent systemic therapy as defined in the protocol
  • Radiation or major surgery within 14 days before the first dose, or not yet recovered from side effects
  • Ongoing immune-related side effects, or serious autoimmune disease within 5 years or treated with immune-suppressing medicine
  • Known allergy to the study drug(s)

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Dose escalation cohorts:
  • Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available; Dose expansion cohorts:
  • Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
  • Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
  • Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
  • Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points

Who cannot take part

  • Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
  • Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
  • Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
  • Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities
  • Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
  • Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments; NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
  • Has known allergy or hypersensitivity to components of the study drug(s)
  • Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention

Where in United States

Also in 4 other countries, 19 sites

  • University of North Carolina at Chapel HillChapel Hill, United StatesContact: Clinical Trials AdministratorTaking people
  • University of ChicagoChicago, United StatesContact: Clinical Trials AdministratorTaking people
  • Start Midwest Cancer ResearchGrand Rapids, United StatesContact: Clinical Trials AdministratorTaking people
  • MD Anderson Cancer CenterHouston, United StatesContact: Clinical Trials AdministratorTaking people
  • Northwell HealthLake Success, United StatesContact: Clinical Trials AdministratorTaking people
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Clinical Trials AdministratorTaking people
  • Yale School of MedicineNorth Haven, United StatesContact: Clinical Trials AdministratorTaking people
  • University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburgh, United StatesContact: Clinical Trials AdministratorTaking people
  • NEXT OncologySan Antonio, United StatesContact: Clinical Trials AdministratorTaking people
  • The START Center for Cancer CareSan Antonio, United StatesContact: Clinical Trials AdministratorTaking people
  • University of California, San Francisco (UCSF)San Francisco, United StatesContact: Clinical Trials AdministratorTaking people

About the trial

What the trial wants to find out

This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage.

Read full original descriptionShow less

The aim of the study is to see how safe, tolerable, and effective the study drug(s) are.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

The 4 groups in the trial

  • Phase 1: Monotherapy Dose EscalationTreatment being tested

    Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D)

    Treatment: REGN10597

  • Phase 2: Monotherapy Dose ExpansionTreatment being tested

    Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants

    Treatment: REGN10597

  • Phase 1: Combination Dose EscalationTreatment being tested

    Multiple DL Cohorts to identify the RP2D

    Treatment: REGN10597 and Cemiplimab

  • Phase 2: Combination Dose ExpansionTreatment being tested

    Cohort 1: Melanoma participants

    Treatment: REGN10597 and Cemiplimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
Plain-language title
Tests REGN10597 alone or with cemiplimab in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 April 2026